MAUDE Adverse Event Report: BEAVER VISITEC INTERNATIONAL LIMITED MALOSA; MALOSA, MICS CAPSULORHEXIS - CURVED/SHAR BX/20

Catalog Number MMSU1567S

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Customer alleged that there were 2 occurrences that a patient's cornea was cut during surgery while using a (mmsu1567s) mics capsulorhexis - curved/sharp.

• Brand Name: MALOSA
• Type of Device: MALOSA, MICS CAPSULORHEXIS - CURVED/SHAR BX/20
• Manufacturer (Section D): BEAVER VISITEC INTERNATIONAL LIMITED; waterloo industrial estate; bidford-on-avon, B50 4 JH,; UK B50 4JH,
• Manufacturer (Section G): BEAVER VISITEC INTERNATIONAL LIMITED; waterloo industrial estate; bidford-on-avon, B50 4 JH,; UK B50 4JH,
• Manufacturer Contact: aminah crawford ; 500 totten pond rd; 10 citypoint; waltham, MA 02451
• MDR Report Key: 17275038
• MDR Text Key: 318655524
• Report Number: 3002808441-2023-00009
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MMSU1567S
• Device Lot Number: 000003451723
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1